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Lupus Erythematosus, Systemic clinical trials

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NCT ID: NCT05358652 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Precision Medicine in LN: A Multicenter Proof-of-concept Study for Histopathological Biomarkers Analysis in Renal Biopsy

Start date: October 15, 2021
Phase:
Study type: Observational

Lupus nephritis (LN) may affect approximately half of patients with Systemic Lupus Erythematosus (SLE). LN is a major cause of morbidity and the most important predictor of mortality in patients with SLE. Some 5-20% of patients with LN may develop end-stage renal disease within 10 years of follow-up from the time of diagnosis. Other studies have described progression to end-stage renal disease in 10-30% of patients with LN. The European League Against Rheumatism, the European Renal Association and the European Dialysis and Transplant Association have recently updated their recommendations for the management of LN. These recommend the use of intravenous (IV) methylprednisolone boluses followed by lower doses of oral glucocorticoids (GC) and place mycophenolate mofetil (MMF) and the European regimen of cyclophosphamide (CYC) as the immunosuppressive drugs of first choice, with the IV CYC regimen for certain more aggressive cases. They also consider the use of "multitarget therapy" based on the combination of tacrolimus (TAC) and MMF and GC in patients with proteinuria in the nephrotic range who have not responded to the first line of treatment. For refractory active renal disease, they recommend as an alternative the use of rituximab (RTX) 1000 mg IV repeated after 15 days. Belimumab has been shown to be significantly more effective than placebo in the treatment of patients with active LN. This finding will lead to positioning belimumab in the therapeutic algorithm for LN. However, in clinical practice these immunosuppressive drugs are not always effective in the treatment of LN, and even one in 3 patients with an initial favorable response may experience renal recurrence. The choice of the appropriate treatment for LN and its early initiation are key to improve the prognosis of these patients and to avoid progression to chronic renal failure. The identification of biomarkers capable of predicting the response (or lack thereof) to one or another therapy at the time of LN diagnosis would allow to implement precision medicine, thus constituting a revolution in the treatment of patients with LN. Allows more targeted treatments with greater specificity to be established. The objective of this project is to analyze histopathological biomarkers in the renal biopsy to predict the renal response to the different drugs used in the treatment of LN. This would contribute to a more specific and cost-effective therapeutic strategy.

NCT ID: NCT05352919 Enrolling by invitation - Clinical trials for Systemic Lupus Erythematosus (SLE)

A Study to Evaluate the Continuous Safety and Efficacy of Litifilimab (BIIB059) in Adults With Active Systemic Lupus Erythematosus

EMERALD
Start date: June 10, 2022
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the long-term safety and tolerability of litifilimab in participants with active systemic lupus erythematosus (SLE). The secondary objectives of this study are to evaluate the long-term effect of litifilimab on disease activity in participants with SLE, to evaluate the long-term effect of litifilimab in participants with SLE in maintaining low disease activity, to evaluate the effect of litifilimab in participants with active SLE in preventing irreversible organ damage, to assess long-term use of oral corticosteroid (OCS) with participants receiving litifilimab treatment, to assess the impact of litifilimab on participant-reported Health-Related Quality-of-Life Questionnaire (HRQoL), symptoms, and impacts of SLE, to evaluate long-term effect of litifilimab on laboratory parameters, and to evaluate immunogenicity of litifilimab.

NCT ID: NCT05347992 Active, not recruiting - Clinical trials for Systemic Lupus Erythematosus

ELEVATE - (Empower Lupus Erythematosus Patients Via Allowing RemoTe Evaluation)

ELEVATE
Start date: May 3, 2022
Phase:
Study type: Observational

To explore the potential for use of DxTerity's AIP IFN-1 test as personalized guided care and monitoring module in patients with Systemic lupus erythematosus(SLE) using consented patient health information

NCT ID: NCT05339217 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Efficacy and Immunological Evaluation of Telitacicept and Low Dose IL2 in the Treatment of Systemic Lupus Erythematosus

Start date: February 7, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study was to explore the clinical and immunological efficacy of Telitacicept and low dose IL-2 on systemic lupus erythematosus.

NCT ID: NCT05329831 Completed - Clinical trials for Systemic Lupus Erythematosus

Effects of Telehealth Initiative on Lupus Patients

Start date: March 15, 2022
Phase: N/A
Study type: Interventional

SLE is mostly seen in young women and causes significant deformity in patients. In SLE, disease activity, body damage due to disease or treatment, comorbidities, and drugs affect body image negatively. SLE causes changes in the body such as skin rashes, uneven pigmentation, vitiligo, scars, tooth loss, alopecia, increased facial hair, stretch marks, weight gain, fatigue, pain, depression, the unpredictability of exacerbations or lack of independence, which worsens the subjective well-being of patients. can affect in that direction. Subjective well-being (SBL) is the scientific term for happiness, and SLE is thought to have a significant negative impact on SWB.

NCT ID: NCT05328557 Active, not recruiting - Clinical trials for Systemic Lupus Erythematosus

A Phase Ia Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered CUG252 in Normal Healthy Volunteers

Start date: November 7, 2021
Phase: Phase 1
Study type: Interventional

The intent of this study is to evaluate the safety and tolerability of single escalating subcutaneous doses of CUG252 in healthy adult subjects.

NCT ID: NCT05326841 Completed - Quality of Life Clinical Trials

Effect of Cholecalciferol Supplementation on Disease Activity and Quality of Life of Systemic Lupus Erythematosus Patients .

Start date: October 3, 2021
Phase: Phase 3
Study type: Interventional

Increase in the prevalence and survival rates has led to the assessment of disease activity and quality of life of SLE patients as targets in treatment. Cholecalciferol supplementation was considered as having a role in reducing disease activity and improving quality of life.This research was a double blind, randomized, controlled trial was conducted on female outpatients aged 18-60 years with SLE, consecutively recruited from September to December 2021 at Cipto Mangunkusumo Hospital. Sixty subjects who met the research criteria were randomized and equally assigned into the cholecalciferol and placebo groups. The study outcomes were measured at baseline and after 12 weeks of intervention. we measured he level of vitamin D before and after intervention, the disease activity by MEX-SLEDAI score and the quality of life by Lupus QoL

NCT ID: NCT05315739 Not yet recruiting - Fatigue Clinical Trials

Vagus Nerve Stimulation for Systemic Lupus Erythematous

SLE-VNS
Start date: May 2022
Phase: N/A
Study type: Interventional

This trial uses a double blinded, randomized 1:1 (active:sham) placebo controlled, parallel group design, investigating the effects of transcutaneous vagus nerve stimulation (tVNS) in patients with systemic lupus erythematosus (SLE). The main objective is to evaluate whether adjuvant treatment with tVNS in SLE patients with signs of autonomic dysfunction and fatigue improves patient perceived levels of fatigue. Secondary outcomes include tVNS induced changes to: patient reported outcomes, autonomic nervous system function, SLE disease activity, immunologic profile, tolerability of pain and organ (cardiac, vascular and kidney) functions. Participants are randomized to received either active non-invasive transcutaneous vagus nerve stimulation (tVNS) or inactive sham stimulation. The study period is divided in two periods. The first period investigates the effects of short-term, high-intensity tVNS treatment. The second phase investigates the effects of long-term, middle-intensity tVNS treatment.

NCT ID: NCT05314881 Not yet recruiting - Clinical trials for System; Lupus Erythematosus

NCF Gene & TNFSF4 in SLE Patients

Start date: April 1, 2022
Phase: N/A
Study type: Interventional

the investigators objective is to identify the association of SNP polymorphisms in the TNFS4, and NCF gene and SLE Egyptian patients.

NCT ID: NCT05306873 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Examining Distinct Immunophenotypes to Validate and Enhance Rational Treatment in Systemic Lupus

DIVERT
Start date: October 28, 2022
Phase: Phase 2
Study type: Interventional

The primary purpose of this study is to evaluate the potential effectiveness of 24 weeks of MMF within previously discovered immunologically defined subsets of SLE patients. Treatment effects will be evaluated within the individual immunologically-homogenous subsets defined at screening. This study will also explore and compare pre-randomization gene expression patterns among responders and non-responders to MMF and MMF plus voclosporin, use comprehensive immunophenotyping to study the immunologic changes that accompany treatment- induced disease improvement and to better understand immunologic changes associated with the loss of clinical response.